Z-2609-2023 Class II Ongoing
FDA device recall Z-2609-2023 was initiated by Randox Laboratories Ltd. on August 3, 2023 and is designated Class II. Reason for recall: there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values prin… The recall status is ongoing. Affected quantity: 66 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- August 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 kits
Product Description
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Reason for Recall
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
Distribution Pattern
US States: GA, OH, OR, PA, TX, VA
Code Information
UDI-DI: 05055273208986; Lot Number: 1308UE