Recall Z-1898-2011 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories Inc
Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Laboratories, Inc. Hercules, CA 94547***" Integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood.
| Date | Apr 6, 2011 (initiated Dec 8, 2009) |
| Status | Terminated |
| Reason | Wrong lot number was found on the Hemoglobin Cartridge Insert . The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD. |
| Root cause | Other |
| Action | The firm, Bio-Rad, sent a "MEDICAL DEVICE CORRECTION" letter dated November 29, 2009 to all customers by Federal Express. The letter described the product, problem and action to be taken. The customers were instructed to do the following: 1) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 80080, please destroy the insert and use the new insert enclosed with the letter. 2) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 90170, they may continue using the insert. 3) |
| Quantity | 51 kits (Lot # 70292242; 45 kits( Lot # 70292318) |
| Distribution | Worldwide distribution: USA including states of: CA, CT, GA, IL, IN, MA, ME, MS, NH, NV, OH, PA, TX, VA and WV; and countries including: France, Hong Kong, Italy, Korea and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063400 | VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 Bio-Rad Laboratories, Inc., Dec 1, 2006 |