FDA Medical Device Recalls (openFDA)
Abbott Gmbh & Co. KG: ARCHITECT HAVAB-G Calibrator, REF 6L27-01
- Recall number
- Z-0574-2020
- Recalling firm
- Abbott Gmbh & Co. KG
- Product
- ARCHITECT HAVAB-G Calibrator, REF 6L27-01
- Status
- Terminated
- Initiated
- 2019-11-07
- Posted
- 2019-11-26
- Terminated
- 2023-08-31
- Reason
- 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.
- Root cause
- Material/Component Contamination
- Action
- 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.
- Quantity
- 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
- Lot, serial or model codes
- lot number 08219BE00
- 510(k) numbers
- ["K113704"]
- PMA numbers
- not on file
- Product code
- LOL
- Firm FEI
- 3002809144
- Firm city
- Wiesbaden
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28