Z-0149-2022 Class II Ongoing
FDA device recall Z-0149-2022 was initiated by Instrumentation Laboratory on August 25, 2021 and is designated Class II. Reason for recall: Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days The recall status is ongoing. Affected quantity: 64,114.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- August 25, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64,114
Product Description
Reason for Recall
Distribution Pattern
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