Nova Biomedical Corporation Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942
Brand
Nova Biomedical Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Domestic S/N: Y01C03200 Y01C03130 Y01104030 Y01104040 Y01104100 Y01104110 Y01304150 Y01304120 Y01104150 Y01104130 Y01104050 Y01104190 Y01104160 Y01104220 Y01204020 Y01204100 Y01204010 Y01204130 Y01204150 Y01204160 Y01703120 Y01304040 Y01304010 Y01304110 International S/N: Inst. S/N Y01204200 Y01304030 Y01304130 Y01304140 Y01304090 Y01304100 Y01104140 Y01204070 Y01204170 Y01104120 Y01C03150
Nova Biomedical Corporation is recalling Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942 due to Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Recommended Action
Per FDA guidance
Nova Biomedical notified users by telephone on 3/31/04 and conducted follow-up by letter either by email or fax. On-site visit will be scheduled to replace the pump assembly.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IL, LA, MA, NJ, NY, OH, PA, TX
Page updated: Jan 10, 2026