HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Reported: December 1, 2021 Initiated: October 13, 2021 #Z-0276-2022
Product Description
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Reason for Recall
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
Details
- Recalling Firm
- Instrumentation Laboratory
- Units Affected
- 5828 kits (310 US)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, IA, IL, KS, ME, MI, NC, NY, OK, SC, and VA. The countries of Canada, Chile, China, Costa Rica, Italy, Japan, and South Korea. ***Updated 3/3/22*** Expansion includes states of IN, MN, and NC.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.. Recalled by Instrumentation Laboratory. Units affected: 5828 kits (310 US).
Why was this product recalled? ▼
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 1, 2021. Severity: Moderate. Recall number: Z-0276-2022.
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