Z-0977-2013Class II

BS-200 Chemistry Analyzer Designed for clinical laboratory use

Name: Z-0977-2013 BS-200 Chemistry Analyzer Designed for clinical laboratory use
Creator: Mindray DS USA, Inc. d.b.a. Mindray North America
Published: 2012-11-28
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2012-11-28 / Terminated / root cause: design

FDA source

Mindray DS USA, Inc. d.b.a. Mindray North America began a recall of BS-200 Chemistry Analyzer Designed for clinical laboratory use on 2012-11-28. FDA classified it as Class II and gives the reason as "An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0977-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-28
Posted: 2013-03-22
Terminated: 2013-06-12
Recalling firm: Datascope Corp.
Product: BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Product code: CFR Hexokinase, Glucose
Reason for recall: An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Root cause tag: design
FDA root cause: Device Design
Action: Mindray North America /Mindray DS USA Inc. sent Urgent Product Corrective Action letters via certified mail, return receipt requested, signature required on 11/28/2012. The letters identified the affected product as well as the issue, effect on patients, and the corrective action. Customers are to remove the analyzer from service until the affected pump has been replaced. Also, customers are to contact Mindray Customer Service Representative Tony Li at 1-800-288-2121 x2112 for technical assistance, and to arrange for replacement pumps at no charge.
Quantity in commerce: 3 units
Distribution: Distributed in the states of NC and TX.
Product codes and lots: Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0977-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0977-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-22

Product code CFR

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)