Recall Z-2609-2023 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories Ltd.
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
| Date | Sep 19, 2023 (initiated Aug 3, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | A Medical Device Correction notification letter dated 8/3/23 was sent to customers. Action to be taken: " Review Quality Control data generated using the affected lot. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you |
| Quantity | 66 kits |
| Distribution | US States: GA, OH, OR, PA, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. Randox Laboratories Limited, Dec 8, 2014 |