ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of
FDA device recall Z-2117-2020 · posted 2020-05-12 · Open, Classified
Recall details
- Recalling firm
- Abbott Gmbh & Co. KG
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LCD
- Quantity affected
- 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, T
- Date initiated
- 2020-04-24
- Date posted
- 2020-05-12
- Location
- Wiesbaden, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (K102699) | Abbott Laboratories | 2011-04-01 |