FDA (Devices) recall action 91148
The FDA (Devices) publishes a recall like this one as 94 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 94 pages.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Biomerieux is recalling PPM Clinical Craponne Chromid VRE culture media because storage conditions (temperature and time) exceeded specifications. Batch 1009540400 was distributed nationwide in the United States.
Biomerieux Inc is recalling PPM CLINICAL CHROMID MRSA 20 PLT diagnostic culture media (84 units) due to temperature and time exceedance during storage that may compromise product performance.
Biomerieux Inc is recalling API 20 C AUX diagnostic strips due to storage conditions that exceeded temperature and time specifications. The manufacturer cannot guarantee product performance.
Biomerieux is recalling 6 units of ETEST Meropenem/Vaborbactam susceptibility test kits (Batch 1008848690) distributed nationwide because they were stored outside specified temperature and time ranges, preventing guarantee of product performance.
Biomerieux is recalling VITEK 2 AST-XN09 test kits where performance cannot be guaranteed due to storage outside proper temperature and time parameters. Affected kits nationwide should not be used.
Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.
Biomerieux Inc. recalled 2 units of BIOBALL A.BRASILIENSIS NCPF 2275 reference standard (Batch 7112) after temperature and time storage conditions exceeded acceptable ranges. The manufacturer cannot guarantee product performance.
Biomerieux Inc has recalled the VITEK 2 Reagent AST-GP78 Test Kit nationwide due to temperature and time storage exceedances that may affect product performance. No illnesses or injuries have been reported.
Biomerieux Inc recalls BIOBALL K.RHIZOPHILA diagnostic kits (batch 7408) due to exceeded temperature and time storage conditions that may compromise product performance.
Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.
Biomerieux Inc is recalling 187 units of VITEK 2 REAGENT AST-GN99 TEST KIT due to storage temperature and time exceedances that may compromise test performance.
Biomerieux is recalling 74 units of PPM Lombard Products TSA 3P neutralizer culture media due to temperature and time storage excursions. Product performance cannot be guaranteed.
Biomerieux Inc is recalling API STAPH 25 diagnostic test kits because storage conditions exceeded safe temperature and time parameters. Product performance cannot be guaranteed for the affected batch.
Biomerieux Inc. is recalling ETEST Clinical Imipenem Relebactam test strips (Catalog 420927) distributed nationwide because the product experienced temperature and time excursions during storage. The manufacturer cannot guarantee the product's test performance.
Biomerieux Inc. is recalling PPM LOMBARD diagnostic products due to storage temperature and time conditions being exceeded during distribution, which compromises the product's guaranteed performance.
Biomerieux Inc. is recalling 15 units of VIDAS VIDAS Salmonella 60T diagnostic test kits (Catalog 30702) because storage conditions exceeded acceptable temperature and time parameters. The affected test kits may not perform reliably.
Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T nationwide due to storage temperature and time deviations that prevent performance guarantee. Batch 1009351560 is affected.
Biomerieux Inc is recalling VIDAS HCG 60 test kits because storage conditions were exceeded, which cannot guarantee product performance. No illnesses or injuries have been reported.
Biomerieux Inc recalled ETEST antibiotic susceptibility test kits from batch 1009384490 due to storage conditions exceeding safe temperature and time parameters, potentially affecting test accuracy.
Biomerieux Inc is recalling PPM Lombard Phosphate Buffer products due to temperature and time exposure during storage or transport that may have compromised product performance.
Biomerieux Inc is recalling PPM Clinical Chromid Candida diagnostic plates because storage temperature and time parameters were exceeded, preventing performance guarantees.
Biomerieux is recalling ETEST Clinical Ceftolozane/Tazobactam S30 diagnostic tests (batch 1009420460) due to storage temperature and time excursions. Product performance cannot be guaranteed, and test accuracy may be affected.
Biomerieux is recalling ETEST Meropenem diagnostic tests because units experienced temperature and time storage excursions that may affect test accuracy. Affected lot 1009462290 was distributed nationwide.
Biomerieux Inc is recalling PPM INDUSTRY COMBOURG BACARA culture plates because they were exposed to improper storage temperatures and duration. Product performance cannot be guaranteed under these conditions.
Biomerieux Inc. is recalling 348 units of VITEK 2 Reagent GN Test Kit due to temperature and time storage parameter exceedance that may affect diagnostic performance. No illnesses reported.