Z-0574-2020Class II

ARCHITECT HAVAB-G Calibrator, REF 6L27-01

Name: Z-0574-2020 ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Creator: Abbott Gmbh & Co. KG
Published: 2019-11-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-11-07 / Terminated / root cause: manufacturing process

FDA source

Abbott Gmbh & Co. KG began a recall of ARCHITECT HAVAB-G Calibrator, REF 6L27-01 on 2019-11-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0574-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-07
Posted: 2019-11-26
Terminated: 2023-08-31
Recalling firm: Abbott Medical
Product: ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Product code: LOL Hepatitis A Test (Antibody And Igm Antibody)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: lot number 08219BE00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0574-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0574-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25

Product code LOL

K113704Class IIArchitect Havab-GAbbott Laboratories / cleared 2012-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)