The Recall Desk
HighFDA (Devices)·Z-0814-2023·Announced 2023-01-11

Biomerieux VITEK MS Clinical Reagent Recall Due to Temperature Excursion

Biomerieux is recalling VITEK MS-DS clinical reagent due to temperature and time conditions that exceeded specification. Thirteen units distributed nationwide cannot guarantee product performance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall. No illnesses or injuries are reported. The hazard is theoretical—product performance degradation is possible but not confirmed to have occurred. Per the rubric, risk-of-harm products without reported injury score at most 3.

Plain-English summary

Biomerieux Inc is recalling VITEK MS-DS clinical reagent (Catalog 410893). Thirteen units with batch number 11111288BM and UDI/DI 03573026359096 were distributed nationwide in the United States.

The recall was initiated because the reagent units were exposed to temperature and time conditions that exceeded specified parameters. According to the manufacturer, when these conditions are exceeded, product performance cannot be guaranteed.

The recalled product

Product
VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
Manufacturer
Biomerieux Inc
Category
Medical Device — Diagnostic Reagent
Hazard
  • temperature-excursion
  • reagent-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 03573026359096
  • Batch Numbers: 11111288BM

Distribution

Distributed nationwide across the United States.

Related recalls

Same category