HemosIL ReadiPlasTin, Part No. 0020301400
Reported: May 18, 2022 Initiated: April 8, 2022 #Z-1052-2022
Product Description
HemosIL ReadiPlasTin, Part No. 0020301400
Reason for Recall
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
Details
- Recalling Firm
- Instrumentation Laboratory
- Units Affected
- 1,563 (US); 29,046 (OUS)
- Distribution
- US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
HemosIL ReadiPlasTin, Part No. 0020301400. Recalled by Instrumentation Laboratory. Units affected: 1,563 (US); 29,046 (OUS).
Why was this product recalled? ▼
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1052-2022.
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