Device product
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Z-2609-2023
Product summary
- Event
- Event 92912
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 66 kits
- Official record key
device-enforcement:Z-2609-2023
Official wording
Reason: 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.
Code information: UDI-DI: 05055273208986; Lot Number: 1308UE
Distribution pattern: US States: GA, OH, OR, PA, TX, VA
Derived failure modes
-
Unknown
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.