ARCHITECT HAVAB-G Calibrator, REF 6L27-01
FDA device recall Z-0574-2020 · posted 2019-11-26 · Terminated
Recall details
- Recalling firm
- Abbott Gmbh & Co. KG
- Reason for recall
- Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpretation from reactive to falsely non reactive. Results impacted may present as a (falsely) non reactive result that fall in the range between 0.50 to 0.99 S/CO.
- Action taken
- The firm initiated the recall by letter on 11/07/2019. The letter explained the issue and requested that the consignee discontinue use of the product and destroy it. The firm is providing replacement material.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- LOL
- Quantity affected
- 83 kits
- Distribution
- US in the states of: AZ, CA, CO, CT, FL, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OR, RI, SC, TN, TX, WA, WV
- Date initiated
- 2019-11-07
- Date posted
- 2019-11-26
- Date terminated
- 2023-08-31
- Location
- Wiesbaden, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARCHITECT HAVAB-G (K113704) | Abbott Laboratories | 2012-06-28 |