TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent sys
FDA device recall Z-1056-2007 · posted 2007-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Reason for recall
- Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.
- Action taken
- The Product Correction Letter dated 3/20/2007, was sent to all customers who received the affected lots. The Customers were instructed to: Determine if they had the lot listed in the Product Correction letter. Inspect each kit of the affected lot and discard any kits incorrectly configured. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them and retain Product Correction letter for their laboratory records.
- Root cause
- Other
- Status
- Terminated
- Product code
- LAO
- Quantity affected
- 1,026
- Distribution
- World wide Distribution : USA including states of AR, CA, CO, CT, DE, FL,GA, ID, IL, IA, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, NJ, NY, NC,NV, OH, SC, PA, RI, TN, TX, UT, WA, WI, WV, Hawaii, Washingt
- Date initiated
- 2007-03-20
- Date posted
- 2007-07-20
- Date terminated
- 2011-06-10
- Location
- Barceloneta, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II (K932615) | Abbott Laboratories | 1993-07-14 |