Z-2163-2012Class II

The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro...

Name: Z-2163-2012 The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro...
Creator: Radiometer America Inc
Published: 2012-07-05
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2012-07-05 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the... on 2012-07-05. FDA classified it as Class II and gives the reason as "A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2163-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-05
Posted: 2012-08-08
Terminated: 2013-08-20
Recalling firm: Radiometer America, Inc
Product: The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t
Root cause tag: software
FDA root cause: Software design
Action: The firm, Radiometer, sent two "Priority Level: Urgent" letters one dated July 9, 2012 and the other dated July 24, 2012 to its affected customers via FedEx with tracking. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the attached Recall Response Fax Form via fax to 800-736-0601. The letter informed the customers that a local service representative will be contacting them shortly to install a software update that will prevent this from occuring (in the event that you utilize HL7 version 2.5 or intend to at some future date.) If you have any questions regarding this letter or the Recall, please contact Radiometer America Technical Support at 1-800-736-0600 opt. 4.
Quantity in commerce: 6854 ABL 7xx units
Distribution: Worldwide distribution: USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech republic, Denmark, Ecuador, Egypt, Eritrea, Estonia, Finland, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Malta, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Qatar, Republic of Korea, Romania, Russia, Saudi Arabia, Switzerland, Singapore, Slovenia, South Africa, Spain, Sweden Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yugoslavia, and Zimbabwe.
Product codes and lots: ABL725: 441R0086N008, 441R0292N010, and 441R0520N009U ABL 735: 441R0050N001, 441R0231N0009, 441R0234N0010, 441R0292N0009, 441R0303N010, 441R0340N004, 441R0343N010, and 441R0522N008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2163-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2162-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08
Z-2163-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08
Z-2164-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08

Product code CHL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)