Radiometer America Inc: S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.

Recall number

Z-1460-06

Recalling firm

Radiometer America Inc

Product

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

Status

Terminated

Initiated

2005-10-31

Posted

2006-08-29

Terminated

2012-04-17

Reason

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.

Root cause

Other

Action

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.

Quantity

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, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV and WY

Lot, serial or model codes

Part #944-025, Lot QR-02, Expiration Date: September 2007.

510(k) numbers

not on file

PMA numbers

not on file

Product code

CHL

Firm FEI

1523456

Firm city

Westlake

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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