Summary
The FDA issued a Class II for HemosIL ReadiPlasTin, Part No. 0020301400 by Instrumentation Laboratory. Reason: Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternati.
Details
Source
Device Recall
External ID
Z-1052-2022
Action Date
2022-05-18
Status
Ongoing
Category
device
Product Description
HemosIL ReadiPlasTin, Part No. 0020301400
Lot/Code Info: UDI 08426950632887 All in-date lots are affected by this recall.
Quantity Affected: 1,563 (US); 29,046 (OUS)
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-08
Company
Bedford, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Instrumentation Laboratory has 39 FDA actions in our database, including 38 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Instrumentation Laboratory) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Instrumentation Laboratory have FDA actions?
Instrumentation Laboratory has 39 FDA actions in our database, including 38 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1052-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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