Recall Z-2117-2020 ยท LCD Enzyme Immunoassay, Gentamicin
Abbott Gmbh & Co. KG
ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
| Date | May 12, 2020 (initiated Apr 24, 2020) |
| Status | Open, Classified |
| Reason | Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted. |
| Root cause | Under Investigation by firm |
| Action | On April 24, 2020, Abbott issued a Product Correction letter to all customers who received shipments of the three impacted lots of ARCHITECT iGenatamicin Reagent kits. U.S. customers were sent the letter via FedEx priority overnight express. In the U.S., the customers will be requested to return to Abbott a Customer Reply Form acknowledging the receipt or a request for assistance. |
| Quantity | 6087 Reagent Kits |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, ND, NE, NJ, NV, NY, OH, OK, PA, RI, SC, TN,TX, UT, VA, VT, WA, WI, PR. The countries of Algeria, Argentina, Australia, Austria, Bahrain, Ba |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102699 | ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS Abbott Laboratories, Apr 1, 2011 |