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Showing 12461–12480 of 35905 results

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Sodium Chloride Injection (ICU Medical) – Sterility Compromise (2022)

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

Class IIModerate

FDANov 9, 2022Nationwide• ICU Medical Inc

Biomerieux Inc: PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CA...

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30...

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

Biomerieux Inc: PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

ENDO Pharmaceuticals Solutions, Inc.: 9 Gauge Disposable Trocars with Blunt Pushers for Use wit...

No expiration dates printed on the packaging

FDANov 8, 2022Nationwide• ENDO Pharmaceuticals Solutions, Inc.

Companion Medical, Inc.: InPen Diabetes Management App, part of the InPen System, ...

Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or isn't responding. After the crash, a present dose reminder is not displayed, which may lead to delayed insulin therapy and potentially resulting in hyperglycemia.

FDANov 8, 2022Nationwide• Companion Medical, Inc.

Foundation Medicine, Inc.: FoundationOne CDx (F1CDx), RAL-0003 version 31.0

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

FDANov 8, 2022Nationwide• Foundation Medicine, Inc.

Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom: Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104....

The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

FDANov 8, 2022Nationwide• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

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