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U.S. Department of Health and Human Services

Class 2 Device Recall BA800M Chemistry Analyzer

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 Class 2 Device Recall BA800M Chemistry Analyzersee related information
Date Initiated by FirmDecember 09, 2019
Create DateJanuary 30, 2020
Recall Status1 Terminated 3 on September 17, 2020
Recall NumberZ-0920-2020
Recall Event ID 84497
510(K)NumberK160370 
Product Classification Electrode, ion specific, sodium - Product Code JGS
ProductBA-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))
Code Information Serial Numbers: W1-6C000006,  W1-71000007,  W1-73000009,  W1-73000010,  XP-68000687T,  W1-71000008,  W1-85000011 
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information ContactDiane Arpino
201-995-8407
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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 Commerce7
DistributionThe products were distributed to the following US states: MI and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JGS
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