Z-1052-2022 Class II Ongoing
FDA device recall Z-1052-2022 was initiated by Instrumentation Laboratory on Apr 8, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1,563 (US); 29,046 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- Apr 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,563 (US); 29,046 (OUS)
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.
Distribution Pattern
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.
Code Information
UDI 08426950632887 All in-date lots are affected by this recall.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1052-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026