bioMérieux, Inc. Issues Urgent Product Correction for VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam

27 October, 2010

bioMérieux, Inc. on September 16, 2010, initiated a worldwide voluntary product correction of VITEK® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZP❷).

These cards, manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® 2 System. Clinical laboratories were notified to perform an alternative method of testing prior to reporting results for:

  • Piperacillin/Tazobactam (TZP❷) and Escherichia coli results 
  • Piperacillin/Tazobactam (TZP❷) and Klebsiella pneumoniae with resistant results

bioMérieux also provided instructions to implement suppression rules to prevent inappropriate reporting of results. Customers can continue to use the VITEK® 2 cards following the guidelines above.

An internal investigation by bioMérieux confirmed user reports that VITEK® 2 antimicrobial susceptibility testing may incorrectly report E. coli and K. pneumoniae susceptible isolates as resistant to Piperacillin/Tazobactam (TZP❷). This same investigation also found that E. coli isolates resistant to Piperacillin/Tazobactam (TZP❷) may be incorrectly identified as susceptible.

Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam when infected with a resistant E. coli isolate. There have been no reports to date of treatment failures associated with either falsely-resistant or falsely-susceptible E. coli results for Piperacillin/Tazobactam (TZP❷), or for falsely-resistant K. pneumoniae results.

Attached below is a list of VITEK® 2 cards that are affected by this product correction. Of these affected cards, all lot numbers currently in distribution, as well as future distribution are affected until further notice. In addition, all new VITEK® 2 cards created that contain TZP❷ are affected by this product correction.

bioMérieux has notified the U.S. Food and Drug Administration (FDA) and is working closely with the agency regarding this urgent product correction. Laboratories with questions should contact bioMérieux, Inc. at 1-800-682-2666, option 3, 24 hours a day; physicians should contact their clinical diagnostics laboratory for additional information if necessary. Consumers with questions should contact their physician.

Adverse reactions or quality problems experienced with the use of the cards should be reported to bioMérieux by contacting Customer Service at 1-800-682-2666, option 3. Customers may also report adverse reactions or quality problems through FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm; by regular mail using the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm; or by fax at 1-800-FDA-0178.

About bioMérieux

A world leader in the field of in vitro diagnostics for over 45 years, bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Our products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. Other information can be found at www.biomerieux.com

Contacts

Media Relations

bioMérieux
Allan Mohess
Tel: +1 919-620-2937
allan.mohess@biomerieux.com

Fleishman-Hillard
Kimberly Mays
Tel : +1 216-928-3459
kimberly.mays@fleishman.com

VITEK® 2 TZP❷ Affected Cards

Card Name
Ref. #
 
Card Name
Ref. #
 
Card Name
Ref. #
 
Card Name
Ref. #
AST-N080
22214
 
AST-N117
22290
 
AST-N152
22347
 
AST-GN22
22227
AST-N081
22215
 
AST-N118
22291
 
AST-N153
22348
 
AST-GN23
22228
AST-N082
22217
 
AST-N120
22293
 
AST-N155
22352
 
AST-GN24
22229
AST-N084
22224
 
AST-N121
22295
 
AST-N156
22353
 
AST-GN25
22230
AST-N085
22225
 
AST-N122
22299
 
AST-N157
22354
 
AST-GN26
22244
AST-N086
22234
 
AST-N123
22301
 
AST-N158
22355
 
AST-GN27
22245
AST-N087
22235
 
AST-N124
22303
 
AST-N159
22356
 
AST-GN28
22254
AST-N088
22236
 
AST-N127
22308
 
AST-N160
22357
 
AST-GN29
22266
AST-N089
22237
 
AST-N128
22309
 
AST-N161
410026
 
AST-GN30
22267
AST-N090
22240
 
AST-N129
22310
 
AST-N162
410023
 
AST-GN31
22268
AST-N091
22241
 
AST-N130
22311
 
AST-N163
410084
 
AST-GN32
22269
AST-N093
22243
 
AST-N131
22315
 
AST-N164
410101
 
AST-GN33
22270
AST-N093
22246
 
AST-N132
22316
 
AST-N165
410102
 
AST-GN34
22271
AST-N094
22247
 
AST-N133
22318
 
AST-N166
410136
 
AST-GN35
22286
AST-N095
22249
 
AST-N134
22319
 
AST-N167
410138
 
AST-GN36
22300
AST-N096
22250
 
AST-N135
22322
 
AST-N168
410139
 
AST-GN37
22312
AST-N097
22251
 
AST-N136
22323
 
AST-N170
410222
 
AST-GN39
22337
AST-N098
22253
 
AST-N137
22324
 
AST-N171
410249
 
AST-GN40
410756
AST-N100
22256
 
AST-N138
22326
 
AST-N172
410298
 
AST-GN41
410757
AST-N103
22259
 
AST-N139
22327
 
AST-N174
410404
 
AST-GN42
410758
AST-N104
22261
 
AST-N140
22328
 
AST-N175
410403
 
AST-GN43
410759
AST-N105
22262
 
AST-N141
22329
 
AST-N176
410402
 
AST-GN44
410805
AST-N106
22264
 
AST-N142
22332
 
AST-N177
410392
 
 
 
AST-N107
22265
 
AST-N143
22333
 
AST-N178
410393
 
 
 
AST-N108
22272
 
AST-N144
22334
 
AST-N179
410640
 
 
 
AST-N109
22273
 
AST-N145
22338
 
AST-N180
410771
 
 
 
AST-N110
22274
 
AST-N146
22341
 
AST-N181
410803
 
 
 
AST-N111
22275
 
AST-N147
22342
 
AST-N182
410804
 
 
 
AST-N112
22281
 
AST-N148
22343
 
 
 
 
 
 
AST-N114
22283
 
AST-N149
22344
 
 
 
 
 
 
AST-N115
22285
 
AST-N150
22345
 
 
 
 
 
 
AST-N116
22289
 
AST-N151
22346

 

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