NRAC Issue #1592 ADDE August 22, 2006 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- PRODUCT a) Liquid Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in serum, Catalog nos. A7516-150, A7516-450, A7516-625, HA716-246, HA716-2400, HA916-302 and HA916-492. In vitro diagnostic RECALL NUMBER # Z-1388-06; PRODUCT b) Liquid Alkaline Phosphatase (R1) Reagent Set for the quantitative determination of alkaline phosphatase in serum, Catalog no. H A416-R1. In vitro diagnostic RECALL NUMBER # Z-1389-06; PRODUCT c) Liquid Alkaline Phosphatase (R2) Reagent Set for the quantitative determination of alkaline phosphatase in serum, Catalog no. H A416-R2. In vitro diagnostic RECALL NUMBER # Z-1390-06; PRODUCT d) Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 8.4 mL and 30 mL containers. In vitro diagnostic RECALL NUMBER # Z-1391-06; PRODUCT e) Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 2.1 mL and 7.5mL containers. In vitro diagnostic RECALL NUMBER # Z-1392-06; PRODUCT f) Liquid Alk Phos Reagent, Catalog no. 3-A7516-L. In vitro diagnostic RECALL NUMBER # Z-1393-06; PRODUCT g) Liquid Alk Phos R1 Reagent, Catalog no. 3-A7516-R1. In vitro diagnostic RECALL NUMBER # Z-1394-06; PRODUCT h) Liquid Alk Phos R2 Reagent, Catalog no. 3-A7516-R2. In vitro diagnostic RECALL NUMBER # Z-1395-06; PRODUCT i) Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent in 50 ml, 120 ml, 2 L and 500 ml containers, Catalog nos. 7-HA716- R1-50-917, 7-A7516-R1-120, 7-A7516-R1-2L, 7-A7516-R1-500, 7-HA716- R1-500, 8-A7516-R1-120 and 8-A7516-R1-500. In vitro diagnostic RECALL NUMBER # Z-1396-06; PRODUCT j) Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers, Catalog nos. 7- A7516-R2-125, 7-A7516-R2-30, 7-A7516-R2-400ML, 7-A7516-R2-90, 8- A716-R2-125, 8-A7516-R2-30 and 8-A7516-R2-90. In vitro diagnostic RECALL NUMBER # Z-1397-06 CODE a) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07); b) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07); c) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07); d) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07); e) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07); f) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07); g) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07); h) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07); i) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07). j) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07) MANUFACTURED & RECALLED BY Pointe Scientific, Inc., Lincoln Park, MI QUANTITY 890 L total DISTRIBUTION Nationwide and Internationally REASON The reagent may be contaminated with microorganisms. ---------------------------------------------------------------------------