Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels
FDA device recall Z-0216-2009 · posted 2008-11-13 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do not perform as intended, the integrity of the system cannot be verified and patient results would not be generated. Other commercially available materials are available to customers in order to meet CLIA requirements.
- Action taken
- A Product Correction, Immediate Action Required letter and Customer Reply Form dated 9/5/08 were sent to all Architect LH MasterChecks (List Number 6C25-05) customers who received Lot 82520M. Customers were informed that the values listed in the Architect LH MasterCheck Lot 82520 data sheet are incorrect. Customers were requested to check their inventory for the affected lot, and if any kits were found, to substitute the values printed on the data sheet with the values supplied in the letter. In addition, Customers were requested to keep a copy of the letter on file and to complete the Customer Reply Form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for the Architect LH MasterCheck testing, and fax it to Abbott by 9/19/08 at 1-800-777-0051. Follow-up telephone calls will be placed to customers who do not provide a written reply via the Customer Reply Form. U.S. Customers please contact Abbott Laboratories Customer Service at 1-877-422-2688 for questions regarding this information.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- JJX
- Quantity affected
- 30 kits
- Distribution
- Nationwide Distribution including Arizona, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Missouri, Montana, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah and Virginia.
- Date initiated
- 2008-09-05
- Date posted
- 2008-11-13
- Date terminated
- 2010-03-18
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 (K984323) | Bio-Rad | 1998-12-15 |