—#107628

Product

Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems The ADVIA Centaur Vitamin D Total (Vit D) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur Vit Assay is intended as an aid in the determination of vitamin D insufficiency. The ADVIA Centaur Vitamin D Diluent 2-pack is used on board the ADVIA Centaur systems to perform automatic and system-performed dilutions fro Vitamin D assay.

FDA product code: MRG — System, Test, Vitamin D
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K110586
Affected lot / code info: Lot # 80230 Expiry Date 04 May 2012

Why it was recalled

Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm, Siemens Healthcare Diagnostics, sent an "Urgent Device Recall Notice" on February 16, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to discontinue using the automatic and system-performed dilution features for Vitamin D; to discontinue the use of ADVIA Centaur VitD Diluent, 2-pack (REF 10494100); to manually dilute samples with values greater than the assay range of 150 ng/mL (375 nmoI/L), using the ADVIA Centaur VitD Diluent, 1 bottle (REF 10632114) as stated in the Vitamin D assay Instructions For Use (IFU); to review the contents of the recall notice with their Laboratory Director and retest the previous sample results generated using system- performed dilutions, and complete and return the confirmation fax-back form via fax to TECHNICAL SOLUTIONS CENTER at (302) 631-7597. If you have any questions or need additional information, please contact your local Technical Support Provider or Distributor or call (508) 668-5000.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) and countries of: Columbia, China, Denmark, Egypt, and Hong Kong.

Timeline

Recall initiated: 2012-02-16
Posted by FDA: 2012-03-21
Terminated: 2013-10-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107628. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.