FDA Device Recalls

Class IIITerminated

The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.

Abbott Molecular

20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe.

March 28, 2013 · DeviceView details →

Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)

LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.

LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.

LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.

LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.

LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.

LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.

LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.

LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.

Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product

Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.

Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.

Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.

Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.

CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.