ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buff

FDA device recall Z-1672-2014 · posted 2014-05-29 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and/or control lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In

Action taken

Product Information letters dated August 23, 2013 were sent to all direct accounts alerting the direct accounts to a positive bias observed in test results using some of the affected kits. The letter advised the direct accounts to take this information into account when interpreting patient results. Customers with questions were advised to contact Customer Service at 877-4ABBOTT (877-422-2688) (24 hours a day, 7 days a week) and to refer to Product Information Letter PI23AUG2013. Product Recall letters dated February 12, 2014 were sent to all direct accounts. The letter included instructions to: 1) immediately discontinue the use of, and destroy, any remaining inventory of ARCHITECT Intact PTH assay according to each customer's laboratory practices; 2) to continue Intact PTH testing at your laboratory, Abbott recommends that customers identify an alternate method for testing patient samples; 3) if further guidance is needed, please contact the customers's Abbott sales representative; 4) review the letter with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary, and that Abbott included a physician letter that you can use to notify your ordering physicians of this issue; 5) If the customer forwarded any product to other laboratories, please inform them of this Product Recall and provide a copy of the recall letter, customer reply, and physician letter to them; and, 6) complete and return the Customer Reply. Customers with questions were advised to contact Customer Service at 877-4ABBOTT (877-422-2688) (24 hours a day, 7 days a week).

Root cause

Under Investigation by firm

Status

Terminated

Product code

JJX

Quantity affected

List Number 8K25-10: 9,463 control kits

Distribution

Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico; Algeria, Andorra, Angola, Argentina, Armenia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgiu

Date initiated

2014-02-12

Date posted

2014-05-29

Date terminated

2015-05-22

Location

Abbott Park, IL

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