ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH,

FDA device recall Z-0816-2014 · posted 2014-01-23 · Terminated

Recall details

Recalling firm

Radiometer America Inc

Reason for recall

RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.

Action taken

Radiometer sent an Urgent Medical Device Recall letter dated November 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check all of their ABL90 FLEX analyzers and ensure that the analyzer is placed on a horizontal platform/table. If the analyzer is placed on a roll stand, please ensure that the support plate is aligned horizontally and locked in this position. Customers were asked to complete and fax the accompanying acknowledgment form in order to confirm their receipt of this field safety notice. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900.

Root cause

Other

Status

Terminated

Product code

JGS

Quantity affected

Total 3414 (US 524, CA 31, ROW 2859)

Distribution

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, W

Date initiated

2013-10-15

Date posted

2014-01-23

Date terminated

2014-06-19

Location

Westlake, OH

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