Reported Jun 4, 2014 · Terminated
ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer…
Abbott Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories · 100 Abbott Park Rd · Abbott Park, IL · 60064-3502
Is this the product you have?
- ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer
- Preservativessodium azide and ProClin 300
- Product UsageThe ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 List Number: 8K25-01. Lot Numbers and Expiration Dates: Lot 00613I000, Expires 05 SEP 2014 2 Lot 01913C000, Expires 14 MAR 2014 3 Lot 01913K000, Expires 12 NOV 2014 4 Lot 02413E000, Expires 09 MAY 2014 5 Lot 01312K000, Expires 12 NOV 2013 6 Lot 00813A000, Expires 08 JAN 2014 7 Lot 01412H000, Expires 16 AUG 2013 8 Lot 00912F000, Expires 30 MAY 2013. - Amount recalled
- 7,780 calibrator kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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