Emd Chemicals, Inc.
United StatesFDA applicant, unverified
- Devices
- 62
- FDA recalls
- 10
What Emd Chemicals, Inc. makes
Emd Chemicals, Inc. manufactures diagnostic reagents and stains for clinical laboratory testing, including uric acid, phosphorus, glucose, cholesterol, creatinine, and iron assays. Their portfolio also covers hematological stains like Wright and Hemacolor stains, as well as immunhematological saline for blood typing. Unitized hematology sets and enzymatic reagents are also part of their product line.
The company’s diagnostic reagents and stains are regulated under FDA’s 510(k) premarket notification process, with devices classified as Class I (general controls) and Class II (special controls). Products are listed in the FDA’s 510(k) database and comply with U.S. regulatory requirements for in vitro diagnostics.
Catalogue
Search and filter all 62 devicesShowing 51-62 of 62
FDA recalls
FDA recall records list 10 recalls initiated by Emd Chemicals, Inc., the earliest on 2002-12-13 and the most recent on 2011-04-04. By recorded status: 10 terminated. The reasons filed fall into these groups: sterility or contamination and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 4 Apr 2011 Z-0043-2012 Unclassified (pre-2012) Terminated Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.
2008
- 2 Jun 2008 Z-2303-2008 Unclassified (pre-2012) Terminated Two complaints that kit was not performing properly with positive controls.
- 27 Mar 2008 Z-1607-2008 Unclassified (pre-2012) Terminated Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.
2007
- 30 Jul 2007 Z-0133-2008 Unclassified (pre-2012) Terminated Out of Spec -- The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.
2006
- 17 Aug 2006 Z-0498-2007 Unclassified (pre-2012) Terminated Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.
- 17 Aug 2006 Z-0499-2007 Unclassified (pre-2012) Terminated Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present
- 25 Jul 2006 Z-0305-2007 Unclassified (pre-2012) Terminated Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly.
2002
- 13 Dec 2002 Z-0683-03 Unclassified (pre-2012) Terminated The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL.
Full distribution text
- 13 Dec 2002 Z-0684-03 Unclassified (pre-2012) Terminated The Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL.
Full distribution text
- 13 Dec 2002 Z-0685-03 Unclassified (pre-2012) Terminated Difficulty in reading slides due to the stain is much greener than normal.
Full distribution text
- 13 Dec 2002 Z-0683-03 Unclassified (pre-2012) Terminated The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL.