ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determ

FDA device recall Z-2172-2013 · posted 2013-09-10 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

Action taken

Siemens sent an Urgent Medical Device Correction letter on July 26, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. an Urgent Field Safety Notice was sent to all domestic customers via Federal Express. On July 25, 2013 this notice was sent to all OUS customers via hard copy, email, and/or fax as determined by each country's local regulations and procedures. These notices inform the customer that a portion of Folate ReadyPacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (QC) and patient results. If customers have an alternate lot of the ADVIA Centaur or ADVIA Centaur CP Folate assay, they are instructed that this lot should be used for future testing. However if no alternative lot is available, quality control (QC) results should be obtained for each individual ReadyPack as a QC or calibration is an indication of an affected pack. An affected pack must be replaced with a different Folate ReadyPack where a valid calibration and acceptable QC values are obtained. These notices should be reviewed by the facility's laboratory or medical director, though no look back is required. Customers were instructed that Fedex Return Receipts will be used to confirm that the customers received the UMDC. Customers with questions were instructed to contact their local Technical Support Provider or Distributor. For questions regarding this recall call 508-668-5000.

Root cause

Material/Component Contamination

Status

Terminated

Product code

CGN

Quantity affected

44

Distribution

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA

Date initiated

2013-07-25

Date posted

2013-09-10

Date terminated

2015-06-12

Location

East Walpole, MA

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