S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood

FDA device recall Z-1460-06 · posted 2006-08-29 · Terminated

Recall details

Recalling firm

Radiometer America Inc

Reason for recall

Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is actually the bar code for the rinse solution.

Action taken

Representatives of the recalling firm were informed of this problem and were asked to visit the firm''s customers and retrieve any of the suspect product found in inventory at each customer location for customer credit. The representatives were instructed to complete this action via a ''Management Cover e-mail issued on 10/31/2005. According to the Management Cover Memo, these actions were scheduled for completion by firm representatives on or before 12/15/2005.

Root cause

Other

Status

Terminated

Product code

CHL

Quantity affected

638/200 mL plastic bottles.

Distribution

The recalled product was distributed to customers in following states nationwide: AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH

Date initiated

2005-10-31

Date posted

2006-08-29

Date terminated

2012-04-17

Location

Westlake, OH