Device Recall Abbott

All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.

Hematology and Pathology Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E. Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.

i-Stat PT/INR Cartridges || List number 03P89-24 || The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. || a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.

Product List Number 07K7220 with Lot #: 55900UI01with expiration date of 04/23/2016, Lot #: 55908UI01 with expiration date of 04/29/2016, Lot #: 55941UI00 with expiration date of 04/23/2016, Lot #: 57929UI00 with expiration date of 07/16/2016, Lot #: 57931UI01 with expiration date of 07/27/2016, Lot #: 60105UI00 with expiration date of 10/02/2016 and Lot #: 61106UI00 with expiration date of 11/27/2016.  Product List Number 07K7225 - Lot #: 55900UI00 with expiration date of 04/23/2016, Lot #: 55908UI00 with expiration date of 04/29/2016, Lot #: 57929UI01 with expiration date of 07/16/2016, Lot #: 57931UI00 with expiration date of 08/27/2016, Lot #: 60105UI01 with expiration date of 02/10/2016, Lot #: 61106UI01 with expiration date of 11/27/2016 and Lot #: 62263UI00 with expiration date of 11/27/2016.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY; and, the countries of ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVI, BRAZIL, BRUNEI, BULGARIA, CAMEROON, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALI, MAURITIUS, MEXICO, MONTENEGRO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TOGO, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM and ZIMBABWE.

The ARCHITECT Estradiol Kit || Intended to measure estradiol, an estrogenic steroid, in plasma.

list 3B42-50, lot 86504M300

Immunology and Microbiology Devices

2

No

Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.

Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbott Park, IL 60064

List number 15252-04-02, lot 940285H

General Hospital and Personal Use Devices

2

No

New Orleans, LA

T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

List number 19020-04-12, lot 941845H

General Hospital and Personal Use Devices

2

No

Miami, FL

Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064