Z-1222-2007

ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect...

Name: Z-1222-2007 ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect...
Creator: Abbott Laboratories
Published: 2007-07-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-07-06 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES... on 2007-07-06. The reason FDA records is "The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits...". 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-1222-2007
Status: Terminated
Initiated: 2007-07-06
Posted: 2007-09-18
Terminated: 2008-05-18
Recalling firm: Abbott Medical
Product: ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and 4 - 2 mL bottles of Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 containing prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers; Abbott Laboratories, Abbott Park, IL 60064, list 6C27-05
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect iSystem Operations Manual.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Abbott sent a Product Correction letter dated 7/6/07, to all customers who received the affected product lot, informing them that the ARCHITECT Prolactin MasterChecks may not be stable at the recommended storage condition of 2 to 8 degrees Celsius (C) through expiration dating (15 months). Labeling is being permanently updated to indicate that ARCHITECT Prolactin MasterChecks are to be stored frozen until first use. After thawing, ARCHITECT Prolactin MasterChecks can be stored unopened at 2-8 degrees C for thirty days or until expiration which ever occurs first. All future shipments will contain updated storage and handling conditions of the ARCHITECT Prolactin MasterCheck. They were requested to check their inventory to see if they have any remaining inventory of lot number 82900M. If they know the date the lot was received or the date it was thawed, they may continue to use the ARCHITECT Prolactin MasterChecks if it has been stored at 2 to 8 degrees C unopened for less than 30 days. If the material has been stored at 2 to 8 degrees C for greater than 30 days or they do not know the number of days it has been thawed, they were instructed to discard the material. Reimbursement for discarded kits will be provided based on information provided in the Customer Reply form. Until labeling is updated, it will be necessary to use an alternate material for verification of sensitivity, calibration linearity, and the reportable range of the ARCHITECT Prolactin assay. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the kits, and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. The accounts were requested to complete and fax back the customer reply form, acknowledging the receipt and understanding of the correction letter. Customers outside of the U.S., were requested to contact their local customer support representative.
Quantity in commerce: 57 kits
Distribution: Nationwide and Canada.
Product codes and lots: list 6C27-05, lot 82900M

Product code JJX

K984324Class IArchitect Prolactin Mastercheck, Model Number 6C27-05Bio-Rad / cleared 1998-12-15

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)