Z-0920-2020Class II

BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring...

Name: Z-0920-2020 BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2019-12-09
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2019-12-09 / Terminated / root cause: manufacturing process

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring))... on 2019-12-09. FDA classified it as Class II and gives the reason as "The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0920-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-09
Posted: 2020-01-30
Terminated: 2020-09-17
Recalling firm: Datascope Corp.
Product: BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The consignee notification was sent certified mail with return receipt verification. The letter identified the affected product, problem and actions to be taken by the Customer/User. Customers were instructed to: Continue to use the system normally and exercise caution when lifting/closing the front and rear cover. Attachment A includes a list of system(s) identified by model and serial number purchased by your company. We recommend that you notify the clients to which you have distributed these systems and advise them to continue normal use with the recommended caution. The gas springs on the systems listed in Attachment A will require replacement and instructions are provided in Attachment B. The parts needed to perform the replacement will be shipped to you within the next several weeks. Type of Action by the Company Mindray will provide replacement gas springs at no cost. Should you require technical assistance while preforming the replacement, please contact Mindrays Technical Support team at 800-288-2121, option 2 (Technical Support), then choose option 3 (IVD Support team).
Quantity in commerce: 7
Distribution: The products were distributed to the following US states: MI and TX.
Product codes and lots: Serial Numbers: W1-6C000006, W1-71000007, W1-73000009, W1-73000010, XP-68000687T, W1-71000008, W1-85000011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0920-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0920-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-30
Z-0921-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-30

Product code JGS

K160370Class IIBS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2016-06-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)